What is Risk-Based Quality Management

Risk-Based Quality Management is a methodology based on the concept of identifying risks on an ongoing basis.

Application of the Methodology

The methodology applies to risk activities during the design, conduct, evaluation and reporting of clinical and pharmaceutical trials.

The process should begin at protocol design time so that mitigation can be built into the protocol. In addition to the mitigation of the risks identified, the opportunity to introduce advantageous and proportionate adjustments to the conventional practices regarding process management, monitoring and conduct must be identified.

Quality management

Risk-based quality management is a systematic process used to identify, evaluate, control, communicate and review the risks associated with a clinical trial throughout its life cycle. The principles of risk management, and the process as outlined in ICH Q92, apply to clinical trials as well as to other areas, such as pharmaceuticals.

ICH Q92

ICH Q92 provides references to various tools that can be used to assist in the risk management process, especially for risk assessment. Applying risk-based quality management approaches to clinical trials can facilitate better, more informed decisions and better use of available resources. Risk management should be appropriate, documented and integrated into existing quality systems.

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